Protocol of EBRAHIP-120: Brazilian randomized controlled trial of uncemented and hybrid hip arthroplasty (Preprint)

Le résumé fourni par la source

BACKGROUND Total hip arthroplasty (THA) is a very successful surgery to treat hip arthritis, improving patients' pain, function, and quality of life. Scarce publications on THA performance with Brazilian manufactured material report results similar to those manufactured in other countries. OBJECTIVE The study aims to compare the clinical, radiographic, function, pain, and quality of life results of patients operated on with a national hybrid prosthesis (with femoral cementation) versus patients operated on with a national uncemented prosthesis. METHODS This study is a single-center, single-surgeon, single-approach, pragmatic, double-blinded, and prospective randomized trial. One hundred and twenty patients will be enrolled in this study and allocated randomly for each group in a 1:1 ratio between two groups: hybrid group (HG) and uncemented group (UG). The participant's incidence of complications (during and after surgery) and their ability to restore anatomical normality parameters on postoperative radiographs will be assessed through radiographic parameters. The participant’s quality of life, joint mobility, function, and satisfaction will also be evaluated using the SF-12 V.2 questionnaire, hip range of motion, Harris Hip Score, and a numeric rating scale. Also, the prosthesis survival rate will be analyzed through the annual frequency revision from 1 year until 5 years, and up to 10 years. RESULTS The project started in October 2024. As of April 2025, we enrolled 72 participants; the first data analysis is expected to be done in November 2025, and the first results are expected to be published in January 2026. CONCLUSIONS This study was approved by the Ethics Committee, and if there are any important protocol modifications, the Ethics Committee will be informed. The study results will be communicated through the paper publication and explained to all the participants who wish to know their results. CLINICALTRIAL The Brazilian Registry of Clinical Trials: RBR-263nf22; https://ensaiosclinicos.gov.br/.

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